GDC-0449: Preliminary Phase II data
Roche said preliminary data from a double-blind, placebo-controlled Phase II trial evaluating 150 mg/day oral GDC-0449 as a single agent maintenance therapy in 104 ovarian cancer patients in second or third complete remission "warrant additional investigation to clarify and interpret potential clinical activity" of the compound. Roche and its Genentech unit plan to further analyze the data, including subset analyses, in the coming months before deciding whether they will continue development of GDC-0449 for the indication.
In June, the partners reported top-line data from a Phase II trial in 195 previously untreated metastatic colorectal cancer (mCRC) patients showing that GDC-0449 plus Avastin bevacizumab and either FOLFOX or FOLFIRI chemotherapy missed the primary endpoint of significantly improving PFS vs. placebo plus Avastin and either FOLFOX or FOLFIRI chemotherapy (see BioCentury, June 21). GDC-0449 also is in a pivotal Phase II trial to treat advanced basal cell carcinoma (BCC), with data expected in 2011. Roche also plans to start a Phase II trial to treat operable BCC this half. ...